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Open Access Highly Accessed Study protocol

Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study

Lydia Roig1, Santiago Perez2*, Gemma Prieto3, Carlos Martin4, Mamta Advani5, Angelina Armengol6, Pilar Roura7, Josep Maria Manresa8, Elena Briones9 and ITADI Study Group

Author affiliations

1 Basic Area of Health La Garriga, Catalan Institute of Health, (Passeig de l'Ametlla,17),La Garriga, (08480), Spain

2 Basic Area of Health La Llagosta, Catalan Institute of Health, (Carrer Vic, s/n), La Llagosta, (08120), Spain

3 Gerencia de Atención Primaria de Ávila, Sanidad de Castilla y Léon, (Avenida Portugal 47), Àvila, (05001), Spain

4 Basic Area of Health Passeig Sant Joan, Catalan Institute of Health, (Passeig Sant Joan 29), Barcelona, (08010), Spain

5 Scientific Area, IDIAP Jordi Gol, (Gran Via de les Corts Catalanes 587) Barcelona, (08007), Spain

6 ABS Terrassa Nord, Catalan Institute of Health, (Carrer Mercè Rodoreda 24) Terrassa, (08207), Spain

7 ABS Badia, Catalan Institute of Health (Carrer Bètica) , Badia del Vallés, (08214), Spain

8 USR Metropolitana Nord, IDIAP Jordi Gol, Sabadell, (08203), Spain

9 USR Barcelona, IDIAP Jordi Gol, (St Elies 42), Barcelona, (08006), Spain

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Citation and License

BMC Public Health 2010, 10:58  doi:10.1186/1471-2458-10-58

Published: 4 February 2010

Abstract

Background

It is a priority to achieve smoking cessation in diabetic smokers, given that this is a group of patients with elevated cardiovascular risk. Furthermore, tobacco has a multiplying effect on micro and macro vascular complications. Smoking abstinence rates increase as the intensity of the intervention, length of the intervention and number and diversity of contacts with the healthcare professional during the intervention increases. However, there are few published studies about smoking cessation in diabetics in primary care, a level of healthcare that plays an essential role in these patients. Therefore, the aim of the present study is to evaluate the effectiveness of an intensive smoking cessation intervention in diabetic patients in primary care.

Methods/Design

Cluster randomized trial, controlled and multicentric. Randomization unit: Primary Care Team. Study population: 546 diabetic smokers older than 14 years of age whose disease is controlled by one of the primary care teams in the study. Outcome Measures: Continuous tobacco abstinence (a person who has not smoked for at least six months and with a CO level of less than 6 ppm measured by a cooximeter) , evolution in the Prochaska and DiClemente's Transtheoretical Model of Change, number of cigarettes/day, length of the visit. Point of assessment: one- year post- inclusion in the study. Intervention: Brief motivational interview for diabetic smokers at the pre-contemplation and contemplation stage, intensive motivational interview with pharmacotherapy for diabetic smokers in the preparation-action stage and reinforcing intevention in the maintenance stage. Statistical Analysis: A descriptive analysis of all variables will be done, as well as a multilevel logistic regression and a Poisson regression. All analyses will be done with an intention to treatment basis and will be fitted for potential confounding factors and variables of clinical importance. Statistical packages: SPSS15, STATA10 y HLM6.

Discussion

The present study will try to describe the profile of a diabetic smoker who receives the most benefit from an intensive intervention in primary care. The results will be useful for primary care professionals in their usual clinical practice.

Trial Registration

Clinical Trials.gov Identifier: NCT00954967